Pearl Technology AG

Address:Wiesenstrasse 33,Schlieren Zurich,CH

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Cradle, Patient, Radiologic (KXH) (10)

Premarket Exempt

Yes

Clear

ProFoam Plate 25x18x5 - 07640178060531 Catalog Number : 1150

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

ProFoam Wedge 18x25x12 - 07640178060548 Catalog Number : 1151

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

ProFoam Wedge 26x25x7 - 07640178060555 Catalog Number : 1152

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

ProFoam Wedge 18x11x5 - 07640178060562 Catalog Number : 1153

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

ProFoam Wedge 36x25x12 - 07640178060579 Catalog Number : 1154

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

ProFoam Wedge 60x25x12 - 07640178060586 Catalog Number : 1155

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

ProFoam Plate 32x32x10 DS - 07640178060593 Catalog Number : 1156

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

ProFoam Plate 32x32x5 DS - 07640178060609 Catalog Number : 1157

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

ProFoam Plate 25x18x5 DS - 07640178060616 Catalog Number : 1159

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

ProFoam Wedge 18x25x12 DS - 07640178060623 Catalog Number : 1159

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

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